Accelerated Degradation Experiment
Conditions
Procedure A: |
30 days exposure at 50 °C and 100% relative humidity. |
Procedure B: |
30 days exposure at 50 °C and 100% relative humidity followed by 7 days at 70 °C and 100% relative humidity. |
Appearance of the substance
The substance, originally in the form of a pale yellow, viscous liquid or a yellow, crystalline, oily solid, changes after procedure B into a chestnut coloured solid.
Gain of moisture
After procedures A and B: 4%
Chromatographic test
Adsorbent: Silica gel F-254
Solution applied to the plate: Substance dissolved in ethane 95%.
Solvent system:
cyclohexane: ..............................30 volumes
acetone: ......................................20 volumes
concentrated ammonia: ................1 volume
Development conditions: The solvent is allowed to migrate until the front reaches a line 15 cm from the starting line.
Detection: The plate is left in a chromatographic chamber containing some iodine crystals until spots appear.
Results: The intensity of the main spots obtained from the solution of the sample subjected to procedure A are decreasing in comparison to the reference solution of fluphenazine decanoate, whereas the intensity of the less mobile secondary spots are increasing. After procedures A and B, the intensity of the secondary spots have decreased even more. The degradation was estimated at about 80%.
Ultraviolet spectrophotometry and colorimetric determination
The spectra of the solutions of each of the samples subjected to procedures A and B remain unchanged.
Conclusion
Fluphenazine decanoate is subject to decomposition under accelerated degradation conditions.
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